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The SiteSeal™ Femoral Compression Device is indicated for use in the compression of the femoral artery or vein after vessel cannulation.

The Site Seal System consists of a Coated Vicryl™ Suture, a hemostatic powder, a spring-loaded polypropylene SiteSeal™ device, tincture of benzoin and four adhesive dressings in a non-sterile kit. Each component in the kit is individually packaged in the original sterile package. The suture is used to approximate soft tissue on either side of and just above a femoral vessel. The hemostatic powder is poured onto the access site and suture entry/exit sites to control minor external bleeding and exudate from sutures and/or endovascular procedures. The free ends of the suture (after approximating the soft tissue on either side and above the CFA with a first half-knot) are tied tightly around the polypropylene SiteSeal™ device with a second full knot to anchor the device to the skin and provide counter pressure. The internal coil springs apply invariant mechanical pressure against the 3-dimensional, asymmetric SiteSeal™ skin contact surface to induce hemostasis. The asymmetric contact surface is designed so that the physical pressure is greatest towards the heart. A polypropylene roof is placed. Tincture of benzoin and three adhesive dressings stabilize and secure the device to the skin. Prior to the patient being ambulated, the transparent adhesive dressing, device, loose powder, and suture are removed. Mechanism of action – A suture is placed in the soft tissue on both sides and above the access site. The "Zstitch" anchors the SiteSeal to the skin surface creating an inverted skin "channel" aligned with the vessel. Hemostatic powder covers the access site and suture penetrations to absorb exudate and control minor external bleeding. The SiteSeal™ device has a three-dimensional skin contact surface that is aligned with the inverted skin channel. The device is pressed tightly against the access site while the sheath is removed. After sheath removal the SiteSeal™ device is anchored to the access site by tying the device to the skin using the loose ends of the suture. Compressed internal springs apply pressure to the skin external to the vessel such that higher pressure is towards the heart. A polypropylene roof is placed securely over the device. Adhesive strips adhere to the roof and stabilize the SiteSeal™ device. The springs help modulate heartbeat pressure variation without stopping blood flow through the vessel. The pressure allows continuous blood flow past the access site for a time sufficient to achieve hemostasis. Hemostasis occurs during the time that the SiteSeal™ device is deployed. The adhesive strip is removed, the sutures are cut and removed, the device is disposed of, any excess powder is brushed off. The patient ambulates immediately. Nothing is left in the body.